Kagoshima Collaborate Trial in Metabolic Syndrome (KACT Study)

Phase 4

• Conditions: Hypertension; Obesity
• Interventions: Drug: Valsartan

• Registration Number: NCT00790946
• Lead Sponsor: Kagoshima University

Brief Summary

The purpose of this study is to consider the following points in patients with hypertension who complicated by metabolic syndrome for Valsartan basis treatment and an existing, standard treatment.

* Blood pressure control

* Changing of adiponectin and plasminogen activator inhibitor-1

* Influence metabolizing and cardiac function, etc.

Detailed Description

The primary endpoints are:

* blood pressure control

* Adiponectin and plasma type1 plasminogen active inhibitor

The secondary endpoints are

* HOMA-IR

* HbA1c

* TNF-α

* IL-6

* Plasma B-type natriuretic peptide

* LVMI

* E/A ratio

* Tei-index

* Apo-J

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2008-10-10
• Study First Submitted QC: 2008-11-13
• Study First Posted: 2008-11-14
• Status Verified: 2008-12
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Last Update Submitted: 2010-06-02
• Last Update Posted: 2010-06-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Out patients with hypertension male and female
• Systolic blood pressure (SBP)≧140mmHg and/or diastolic blood pressure (DBP)≧90 mmHg
• Waist Surrounding diameter male≧85cm female≧90cm
• Patient who is treating either high triglyceride,low HDL,or diabetes mellitus
• Patient who is untreatment high triglyceride blood syndrome and low HDL blood syndrome,diabetes mellitus is triglceride≧150mg/dl and/or HDL cholesterol < 40 mg/dl or fasting blood glucose ≧110 mg/dl
• Untreated patients with hypertension,or patients is treated with antihypertensive agents except for ACE-I and ARB

Exclusion Criteria

• Patient who is using ACE-I and ARB
• Serum creatinine ≧ 3 mg/dl
• Liver impairment
• History of allergy to valsartan
• Pregnant women
• Judgment by the physician that participation was unwise on the basis of patient characteristics and drug safety

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Valsartan	Valsartan	Valsartan 80 to 160mg

Primary Outcome Measures

Name	Time	Method
Blood Pressure, Adiponectin and PAI-1 concentration	1 year

Secondary Outcome Measures

Name	Time	Method
TNF-α	１ year
IL-6	1 year
BNP	1 year
LVMI	1 year
E/A ratio	1 year
Tei-index	1 year
Apo-J	1 year
HbA1c	1 year
HOMA-IR	1 year

Trial Locations

Locations (1)

Chuwa Tei,MD,FACC,FAHA; 🇯🇵 Kagoshima, Japan